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Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents

NCT00195767 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2007-03-19

No results posted yet for this study

Summary

To determine if long-term treatment, up to 6 months, with Depakote ER is safe and effective in the treatment of bipolar I disorder in children and adolescents.

Conditions

  • Bipolar I Disorder, Manic or Mixed

Interventions

DRUG

divalproex sodium

Sponsors & Collaborators

Principal Investigators

  • Global Medical Information 800-633-9110 · Abbott

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00195767 on ClinicalTrials.gov